RE:RE:RE:RE:RE:POC I admit that the definition I provided is quite stringent.It is only one of many definitions found on Google but my point was none of the definitions that I saw were based on a hunch... which Is what I think Spceo and others are at now.Imo it makes absolutely no sense to say that "the key attributes for success are in place and the key causes of failure are absent".
I have lost a lot of money in the past in biotechs showing a lot of exhuberance which all ended up in the gutter ....
A substantial investment by a partner will cause my heartbeat to rise .....especially from a large pharma
but I would also be pleased with an investment from China but not as much....
qwerty22 wrote:
All this is very slippery. If you are ultra-cautious then you wait. The company is never going to get ahead of the data so they probably wait. I think SPCEO tends to project forward based on what we have now so there is less waiting on his part. I'd be closer to the company than to SPCEO on this issue.
What the company could do at this point that they haven't done is be really clear about what happened on the safety side. I really want a very clear list of the AEs from the 300/360 doses of the drug. I'm piecing together a pretty positive picture of the safety profile from a number of different statements. But at the same time I'm aware that each of those statements could be a cherry picked picture of only a part of the data. I hope when the investor presentation goes up they will have a page setting out clearly all the AEs from at least the 300/360 doses. Beyond that I'm pretty happy we know the state of play so far.
qwerty22 wrote:
ORR and PFS are really the endpoints they are aiming for to get approval. Would these be the "key attributes of success"? In which case we are still a long way from POC based on this definition because we know nothing about these.
I don't like Palinc's definition because it seems to me it really needs some evidence about what is happening at the population level and we are a long way from that.
JFM called what we have anecdotal. Another way to say that is knowing what has happened at the individual level. In that case a good way to think about it is have they proved th1902 has anti-tumour activity. Either making tumours shrink or stopping tumours growing. That would be what the 53% Partial Response patient and the patient with SD for 11 cycles would suggest. As I keep saying the presence of free docetaxel complicates the issue. If you believe the supporting issue around docetaxel being ineffective in these patients as shown by their previous failure on these drugs then we can be certain of anti-tumour activity.
The next step for POC is to take that initial observation of anti-tumour activity and explore a particular population to see how that manifests itself in terms of ORR and PFS. The 1b trial first 10 patients give a crude look at that. An expanded cohort to 25 will give us a pretty good idea where these will land, that I think is the strength of an expansion group.
So again POC is a slippery term.
If you think it revolves around ORR and PFS then we are a long way from it.
If you think it's about showing anti-tumour activity then that is where we are right now. The one confounding factor is "free docetaxel"
If you think they have adequately dealt with free docetaxel then we can assign anti-tumour activity to Th1902 and we have our POC based on anti-tumour activity.
My view is the free docetaxel issue is not completely dealt with. The evidence is too thin but what evidence that does exist is directionally correct. They will get more evidence that is inevitable. There won't really be a gotcha moment because directly distinguishing between free docetaxel activity and th1902 activity is pretty difficult. It will likely be the case of accumulating more directionally correct data.
What I'd like is if they could show the presence of the MDR marker in the tumour material of a responding patient. If they could show responders have good Sortilin levels. And if the could just show one or two more responders that previously failed on taxanes. That would nail the issue of free docetaxel for cautious individuals. We have a little bit of that with the first 1a data. It should be possible to get the rest from the first 1b interim data readout. If you're less cautious you could easily start betting on the data we already have.
palinc2000 wrote:
Everyone is entitled to his opinion .My bigger point is that there has been a lot of rants here with a lot of blame agsinst management because people without scientific knowledge actually think that you are right about the likelyhood of success and cannot comprehend why mgmt is bot spreading the good news across the universe!!!
IF and when there are facts that support a probability of success you will hear about it on TV and read about it everywhere.
Of course everyone is free to believe that success is at hand but so far I have not seen anyone on this board doing any buying even though the best time to buy is NOW if of course you have faith in your opinion
Could management present a rosier picture of the company as a whole ? I think Scarlett had a post the other day with a list of items /facts which could be better disseminated .I do believe that the market cap of THTX is undervalued and should be at least double just based on its commercial activities but I think the market needs to see the pudding in the next 2 quarters
SPCEO1 wrote: Everyone will have their opinion on this but my read is we re already at a point where it is reasonably likely the key attributes for the success of TH-1902 are in place and th ekey causes of failure are absent.
palinc2000 wrote: A Google search of POC will lead to many many definitions none of which to suggest that we are at that point ATM ....
What is worst than fuzzy math is fuzzy science data ...
When and if POC is attained we will know just by seeing the market reaction $$$
“Proof of concept may be defined as the earliest point in the drug development process at which the weight of evidence suggests that it is "reasonably likely" that the key attributes for success are present and the key causes of failure are absent.” POC is a key translational pivot point ...